Clinical Trials Logo

Clinical Trial Summary

Fetal heart rate [FHR] monitoring is used widely to assess the well-being of the baby in the delivery period. If it is determined that an urgent cesarean delivery is required because of fetal distress, FHR is discontinued once the mother is in the operating room in order to allow for surgical site preparation. From this point, there is no real-time monitoring that permits assessment of the well-being of the infant. The investigators are evaluating the feasibility of intraoperative FHR monitoring using fetal ECG placed on the mother's upper abdominal wall and the standard acoustic device routinely used. The investigators will compare these to the traditional well-being tests: umbilical arterial blood gas and Apgar score.

The first 15 subjects will be recruited from pregnant women who have scheduled induction of labor. The subsequent 40 subjects will be recruited from pregnant women who have scheduled cesarean sections.


Clinical Trial Description

Fetal heart rate (FHR) monitoring has become the most widely used assessment of fetal well-being in the peripartum period and the only routinely used method that provides continuous fetal monitoring. Despite a false positive rate for the detection of intrapartum asphyxia leading to cerebral palsy of over 99% [1-3] FHR monitoring continues to be the mainstay of peripartum fetal surveillance. FHR monitoring is routinely available in the operating room, where it is typically reassessed in cases of urgent cesarean delivery for fetal distress since it may direct immediate anesthetic and peripartum management. However, despite the ubiquitous use of FHR monitoring in labor and the typical use of FHR monitoring on arrival to the OR, FHR monitoring is universally stopped once anesthesia has been performed in order to allow abdominal skin preparation and for surgery to proceed. From the moment of anesthesia induction until fetal delivery, no real-time data is available that allows assessment of fetal well-being. A few isolated studies and case reports in the 1970s-1980s examined intraoperative FHR monitoring using scalp-clip electrodes during Cesarean deliveries [4-7]. None of these studies assessed external FHR monitors or current anesthesia techniques. To the investigators' knowledge no studies since that time have examined FHR monitoring during Cesarean deliveries using external monitoring or spinal anesthesia ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02950896
Study type Observational
Source Washington University School of Medicine
Contact
Status Terminated
Phase
Start date October 2016
Completion date October 29, 2017

See also
  Status Clinical Trial Phase
Completed NCT03244865 - Refinement of the OBMedical LaborView System
Not yet recruiting NCT05933928 - The Effect of Simulation-based Electronic Fetal Monitoring Training on Midwifery Students N/A
Completed NCT04779294 - The Oslo Stan vs Lactate Observational Study
Recruiting NCT05938790 - Point of Care Ultrasound in Obstetric Triage N/A
Not yet recruiting NCT05510349 - Prevention of Per-partum Fetal Hypoxia: Measure of Placental Elasticity and Viscosity During Labor N/A
Not yet recruiting NCT03268486 - Evaluation of a Novel Signal Acquisition Technique for Intrapartum Cardiotocography N/A
Recruiting NCT06135961 - Intrapartum Non-invasive Electrophysiological Monitoring N/A
Recruiting NCT05847790 - Remote Pregnancy Monitoring to Improve Access N/A
Completed NCT02790554 - Moyo; strap-on Fetal Heart Rate Monitoring in an Urban Setting N/A
Completed NCT05060172 - A Clinical Study for Validating the Equivalence of Bloomlife MFM-Pro to Clinical Standard-of-care for Antepartum Fetal Monitoring N/A
Recruiting NCT03111173 - Can Conventional ECG Technology Capture Fetal Cardiac Activity? N/A
Recruiting NCT05665400 - A Clinical Study for the Development of a Device (Lovelace) for Antepartum Fetal Monitoring N/A
Completed NCT02790814 - Moyo; strap-on Fetal Heart Rate Monitoring in a Rural Setting N/A
Completed NCT05863156 - Evaluation of the Effects of Different Positions Given During Antenatal Electro-Fetal Monitoring N/A
Completed NCT04915131 - A Clinical Study for Validating the Equivalence of Bloomlife MFM-Pro to Clinical Standard-of-care for Performing Antepartum Fetal Monitoring N/A